Page 14 - Safety Risk Management for Medical Devices

LIST OF FIGURES

Figure 2.1 Overengineered Cowboy 6
Figure 3.1 Hazard Theory 13
Figure 4.1 ISO 14971 Figure E.1 19
Figure 4.2 5-Scale Risk Estimation 20
Figure 5.1 ISO 14971, a Central Standard 24
Figure 8.1 Type of Normal Use 34
Figure 8.2 Model of User-Medical Device Interaction 35
Figure 10.1 System Decomposition 46
Figure 11.1 The BXM Risk Management Process 50
Figure 11.2 Risk Reduction End-Point Logic (with SOTA) 57
Figure 11.3 Risk Reduction End-Point Logic (without SOTA) 58
Figure 11.4 Example Risk Profile 59
Figure 11.5 Harms Assessment List Creation Via Expert Opinion 65
Figure 12.1 Example of Fault Tree Analysis Diagram 69
Figure 12.2 Fault Tree Analysis Symbols 72
Figure 12.3 Alternate Fault Tree Analysis Symbols 73
Figure 12.4 Example of Mind Map 76
Figure 12.5 Multilevel Hierarchy 82
Figure 12.6 Electronic Thermometer 83
Figure 12.7 Failure Theory 83
Figure 12.8 Integral Systems—System D/PFMEA to RACT Flow 91
Figure 12.9 Distributed Systems—System DFMEA to RACT Flow 91
Figure 12.10 Relationship Between Use-Misuse Failure Modes and Effects Analysis 92
(UMFMEA) and the Risk Assessment and Control Table (RACT)
Figure 12.11 Information Flow Between Failure Modes and Effects Analysis (FMEA) 93
Levels
Figure 12.12 Interface Example 94
Figure 12.13 When End Effect and Failure Mode are the Same 103
Figure 12.14 Use-Scenario Inventory 114
Figure 12.15 P-Diagram 118
Figure 14.1 Safety and Security Relationship 124
Figure 14.2 Exploitability Versus Harm Severity 125
Figure 15.1 Contribution of Software to Hazards 128
Figure 15.2 Software Chain of Events to System Hazards 130
Figure 15.3 Software Safety Classification Process 140
Figure 15.4 Automatic Sphygmomanometer 147
Figure 16.1 Failure Modes and Effects Analysis Integration 151

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